Trial · NCT01752400

AUY922 for Advanced ALK-positive NSCLC

NCT01752400, Phase 2, Completed, Massachusetts General Hospital; results first posted 2018-03-29

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. AUY922 for Advanced ALK-positive NSCLC. Trials, record NCT01752400. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01752400

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: AUY922 for Advanced ALK-positive NSCLC
NCT number: NCT01752400
Status: Completed
Phases: Phase 2
Enrollment: 6 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Non Small Cell Lung Cancer
Interventions: AUY922
First posted: 2012-12-19
Last updated: 2018-03-29
Results first posted: 2018-03-29

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response Rate	Baseline and then every six weeks (± 7 days), until the time of disease progression	The number of participants that achieved either a complete response (CR) or a partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \< 10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Secondary	Progression-free Survival	From the start of treatment until the time of death or progression	Progression free survival is measured as the number of months from date of study entry to date of progression or death, whichever comes first. Progression is assessed using RECIST v1.1. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression.
Secondary	Disease Control Rate	Baseline and then every six weeks (± 7 days), until the time of disease progression	The number of participants that achieved disease control, which includes complete responses, partial responses or stable disease as assessed by RECIST v1.1 * Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to \< 10 mm. * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. * Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Secondary	Number of Participants Who Develop Adverse Events on AUY922	From the start of treatment until 30 days after last dose was received	The number of participants that developed any grade adverse event as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
Secondary	Number of Participants With Concurrent KRAS Mutations	Baseline
Secondary	ALK Translocation Variant Type	Baseline
Secondary	ALK Mutation Status	Baseline, end of treatment	The number of secondary ALK mutations or ALK amplification as a mechanism of resistance in pre-treatment and post-treatment biopsies.
Secondary	Median Overall Survival	From the start of treatment until death or withdrawal from the study	The median duration of time from the start of treatment until the time of death or until the participant withdraws participation in the trial.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate	Baseline and then every six weeks (± 7 days), until the time of disease progression		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression-free Survival	From the start of treatment until the time of death or progression		Months	MEDIAN
SECONDARY	Disease Control Rate	Baseline and then every six weeks (± 7 days), until the time of disease progression		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Develop Adverse Events on AUY922	From the start of treatment until 30 days after last dose was received		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Concurrent KRAS Mutations	Baseline		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	ALK Translocation Variant Type	Baseline	Data unavailable for all six participants
SECONDARY	ALK Mutation Status	Baseline, end of treatment	Data not available for the other 5 participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Overall Survival	From the start of treatment until death or withdrawal from the study		Months	MEDIAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Objective Response Rate	AUY922		0		Participants
Progression-free Survival	AUY922		1.43	95% Confidence Interval 1.3 to 2.8	Months
Disease Control Rate	AUY922	CR	0		Participants
Disease Control Rate	AUY922	PR	3		Participants
Disease Control Rate	AUY922	SD	3		Participants
Number of Participants Who Develop Adverse Events on AUY922	AUY922		6		Participants
Number of Participants With Concurrent KRAS Mutations	AUY922	KRAS Mutation	0		Participants
Number of Participants With Concurrent KRAS Mutations	AUY922	Negative for KRAS Mutation	2		Participants
Number of Participants With Concurrent KRAS Mutations	AUY922	Unknown Mutation Status	4		Participants
ALK Mutation Status	AUY922	ALK Mutation	1		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AUY922	6
Overall Study	COMPLETED	AUY922	6
Overall Study	NOT COMPLETED	AUY922	0

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal pain	Gastrointestinal disorders	AUY922	2	6	3
other	Alanine aminotransferase increased	Investigations	AUY922	1	6	1
other	Alkaline phosphatase increased	Investigations	AUY922	2	6	2
other	Alkalosis	Metabolism and nutrition disorders	AUY922	1	6	1
other	Anemia	Blood and lymphatic system disorders	AUY922	1	6	1
other	Anorexia	Metabolism and nutrition disorders	AUY922	1	6	1
other	Anxiety	Psychiatric disorders	AUY922	1	6	1
other	Aspartate aminotransferase increased	Investigations	AUY922	1	6	2
other	Constipation	Gastrointestinal disorders	AUY922	2	6	2
other	Diarrhea	Gastrointestinal disorders	AUY922	4	6	5

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AUY922	1	6
Total, other adverse events	AUY922	6	6
Total, serious adverse events	AUY922	2	6

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01752400

GET https://conductscience.org/api/trials/v1/NCT01752400/events?page=2

API reference For AI assistants